Query: container closure integrity study methodology

Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0071. Type: deficiency. Risk: low. Category: Nonclinical.

Correspondence ID
COR-371
Type
deficiency
Application
TFDA-2024-0071
Authority
Taiwan Food and Drug Administration
Category
Nonclinical
Risk
Low
Due Date
2024-12-27
Status
In Progress
Owner
Tomoko Ikeda
Created
2022-10-26
Correspondence Body
Dear TFDA Review Team, With reference to application TFDA-2024-0071, we wish to address the following: [Detailed response body regarding query regarding bioequivalence study design] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_371_1.pdfdata_table_371.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.